Dupuytren's Contracture

Do not receive XIAFLEX® if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX®, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX®.

XIAFLEX® can cause serious side effects, including:

Tendon rupture or ligament damage. Receiving an injection of XIAFLEX® may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit

Nerve injury or other serious injury of the hand. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit

Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX® because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX®:

hives

swollen face

breathing trouble

chest pain

low blood pressure

dizziness or fainting

Increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX®. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX® may not be right for you.

Before receiving XIAFLEX®, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX® injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using XIAFLEX® with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX® injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines if you are unsure.

The most common side effects with XIAFLEX® for the treatment of Dupuytren’s contracture include:

swelling of the injection site or the hand

bruising or bleeding at the injection site

pain or tenderness of the injection site or the hand

swelling of the lymph nodes (glands) in the elbow or armpit

itching

breaks in the skin

redness or warmth of the skin

pain in the armpit

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX®. For more information, ask your healthcare provider or pharmacist.

What is XIAFLEX®?

XIAFLEX® is a prescription medicine used to treat adults with Dupuytren’s contracture when a “cord” can be felt. It is not known if XIAFLEX® is safe and effective in children under the age of 18.

Peyronie's Disease

Do not receive XIAFLEX® if you:

have been told by your healthcare provider that the Peyronie's plaque to be treated involves the "tube" that your urine passes through (urethra)

are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX®, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX®

XIAFLEX® can cause serious side effects, including:

Penile fracture (corporal rupture) or other serious injury to the penis.Receiving an injection of XIAFLEX® may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX®, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.

After treatment with XIAFLEX®, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin

Symptoms of corporal rupture or other serious injury to your penis may include:

a popping sound or sensation in an erect penis

sudden loss of the ability to maintain an erection

pain in your penis

purple bruising and swelling of your penis

difficulty urinating or blood in the urine

Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above.

Do not have sex or any other sexual activity between the first and second injections of a treatment cycle.

Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX® and after any pain and swelling has gone away.

XIAFLEX® for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX® Risk Evaluation and Mitigation Strategy (REMS) Program. For more information about the XIAFLEX® REMS Program, go to www.XIAFLEXREMS.com or call 1‑877‑942‑3539.

Hypersensitivity reactions, including anaphylaxis.Severe allergic reactions can happen in people who receive XIAFLEX®, because it contains foreign proteins.

Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX®:

hives

swollen face

breathing trouble

chest pain

low blood pressure

dizziness or fainting

Before receiving XIAFLEX®, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX® injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non‑prescription medicines, vitamins, and herbal supplements. Using XIAFLEX® with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX® injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines if you are unsure.

What should I avoid while receiving XIAFLEX®?Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements.

Do not use a vacuum erection device during your treatment with XIAFLEX®.

XIAFLEX® can cause serious side effects, including increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX®. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX® may not be right for you.

The most common side effects with XIAFLEX® for the treatment of Peyronie's disease include:

a small collection of blood under the skin at the injection site (hematoma)

swelling at the injection site or along your penis

pain or tenderness at the injection site, along your penis and above your penis

penis bruising

itching of your penis or scrotum (genitals)

painful erection

erection problems (erectile dysfunction)

changes in the color of the skin of your penis

blisters at the injection site

pain with sex

a lump at the injection site (nodule)

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects with XIAFLEX®. For more information, ask your healthcare provider or pharmacist.

What is XIAFLEX®?

XIAFLEX® is a prescription medicine used to treat adult men with Peyronie's disease who have a "plaque" that can be felt and a curve in their penis greater than 30 degrees when treatment is started.

It is not known if XIAFLEX® is safe and effective in children under the age of 18.